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Completed

NCT Number: NCT06187363

Redo Repair in Disrupted Hypospadias

Redo hypospadias repair is a challenging situation and its success depends on many factors. Several procedures could be used in such situations with variable outcomes. The investigator in this study aimed at comparing the results of these procedures

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Key information

Conditions

Hypospadias Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Penile Diseases Urogenital Abnormalities Urogenital Diseases

Sex eligibility

Male

Study type

Observational

Primary location

Faculty of Medicine

Alexandria, 12345, Egypt

About this study

Purpose: Our study compared the outcome of the tubularized incised plate urethroplasty procedure and other procedures in the case of redo hypospadias repair. Methods: The participants were categorized into those who were treated by the tubularized incised plate procedure (Group A) and those who were treated by other procedures (Group B) and the collected data were compared between the two groups. The patients were examined regularly during the postoperative period for urethral-cutaneous fistula, meatal stenosis, penile curvature, penile skin coverage, and re-disruption.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients with disrupted hypospadias repair

Exclusion criteria

  • Fresh cases of hypospadias

Treatment and study plan

Tubularized incised plate procedure

Procedure

Tubularized incised plate urethroplasty procedure

Other procedures

Procedure

Other procedures than tubularized incised plate urethroplasty procedure

Primary outcomes

  1. The number of participants who developed post-operative meatal stricture

    Time frame: at 1 month, 3 months, 6 months, and at the end of the 1st year

    assessment of the position of neo-meatus in glans together with its diameter as well as the presence of stenosis as judged by urethral calibration

  2. The rate of development of recurrent post-operative chordae

    Time frame: at 1 month, 3 months, 6 months, and at the end of the 1st year

    The recurrence of ventral penile chordae as discovered by recurrent ventral penile curvature

  3. The incidence of development of postoperative penile skin scarring

    Time frame: at 1 month, 3 months, 6 months, and at the end of the 1st year

    Assessment of penile skin coverage as judged by the development of recurrent curvature, torsion and/or disfigurement

  4. The incidence of the development of failed repair as discovered by the position of the neo-meatus

    Time frame: at 1 month, 3 months, 6 months, and at the end of the 1st year

    Re-disruption the reposition of the neo-meatus to the previous site

  5. The incidence of the development of post-operative urethral-cutaneous fistula

    Time frame: at 1 month, 3 months, 6 months, and at the end of the 1st year

    The development of post-operative urethral-cutaneous fistula as judged by the development of a second urethral openning proximal to the neo-meatus

Sponsors and collaborators

Lead sponsor

Egyptian Biomedical Research Network

Network

Registry information

Official study title

Tubularized Incised Plate (TIP) Procedure Versus Other Procedures in the Repair of Disrupted Hypospadias

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 2, 2024
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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